Article R1243-10
The authorisations referred to in Article R. 1243-6 may be suspended or withdrawn in whole or in part, pursuant to Article L. 1245-1, and in particular in the event of danger to public health or the e…
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Showing 51–60 of 38628 articles for “Art. L 1243-11”
The authorisations referred to in Article R. 1243-6 may be suspended or withdrawn in whole or in part, pursuant to Article L. 1245-1, and in particular in the event of danger to public health or the e…
The person in charge referred to in Article R. 1243-12 and the interim persons in charge, as well as the person in charge of activities, shall hold diplomas entitling them to practise medicine or phar…
Any changes relating to :1° The name or administrative address of the establishment or organisation, or where applicable the authorised site;2° The appointment of a new director of the establishment o…
Within two months of the date on which the dossier is deemed to be complete, the Minister for Research and, where applicable, the Director General of the Regional Health Agency may, in the cases provi…
When they are distributed or transferred, the tissues, their derivatives, the cells or the cell therapy preparations are accompanied by the documents mentioned in Article R. 1211-19 and Article R. 121…
The authorised establishment or body sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Agence de la biomédecine, as…
I.-The application for authorisation provided for in Article L. 1243-2 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the legal ent…
Applicant establishments or organisations appoint a responsible person who ensures compliance with the regulations relating to the quality and safety of tissues or their derivatives or cell therapy pr…
Within the scope of the declaration, organisations must be able to provide the following information at any time: 1° The nature and number of samples held; 2° The characteristics of the samples held;…
Authorised bodies must be able to provide the following information at any time: 1° The nature and number of samples held ; 2° The characteristics of the samples held; 3° How the samples are prepared;…
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